How FDA and Industry Aim to Find and Eliminate Drug Recalls' Root Causes
This article was originally published in The Gold Sheet
Rooting out recalls: FDA to inspect for common causes of recalls identified in ongoing study. Findings on subpotency and B. cepacia shared. Consultant offers process for root cause analysis.
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Another outbreak of B. cepacia at hospital intensive care units in multiple states implicates manufacturing and supply chain controls on aqueous non-sterile drug products, particularly for those marketed over the counter under OTC monographs.
FDA examines field alert report data for early warnings of emerging quality issues, but finds only questions as many companies submit few if any FARs to the agency. Meanwhile, some manufacturers are finding benefits from reporting and dealing with drug defects and errors, improving corporate culture and in one case saving nearly $1 billion.
When Lynn Torbeck undertook a three-year root cause analysis of drug recalls, he thought he knew what he would find out.